Claw ToeNCT03530839
Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty
A study testing Arthrodesis and Resection arthroplasty in people with Claw Toe and Lesser Toe Deformity, run by University Hospital Tuebingen.
Trial summary
Background: The aim of this study was to compare operative outcomes after lesser toe deformity correction with either proximal interphalangeal (PIP) joint arthrodesis or PIP joint resection arthroplasty. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Claw Toe, Lesser Toe Deformity
- What is being tested?
- Arthrodesis and Resection arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with one or more claw toes with rigid PIP joint flexion and extension deformity of the MTP joint scheduled for surgical intervention in the investigator's department
Who cannot join
- known osteoporosis or other bone metabolism disorders
- prior surgery on the toe scheduled for the intervention
- immunodeficiency or immunosuppressive drug intake
- pregnancy
- non-palpable pulses of the posterior tibial artery or the dorsalis pedis artery
- anticoagulation therapy with the exception of acetylsalicylic acid
- a lack of sufficient physical resilience to allow free self-mobilization and walking.
About this study
Official title: Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty: A Randomized Controlled Study
Background: The aim of this study was to compare operative outcomes after lesser toe deformity correction with either proximal interphalangeal (PIP) joint arthrodesis or PIP joint resection arthroplasty.
Methods: A prospective randomized controlled trial was performed on 37 patients (48 toes) who underwent one of these two procedures. The Numeric Rating Scale (NRS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) score, osseous consolidation, and clinical outcome were evaluated preoperatively and at 6 weeks and 6 months postoperatively.
- Conditions
- Claw Toe, Lesser Toe Deformity
- Being tested
- Arthrodesis, Resection arthroplasty
- Keywords
- lesser toe deformity, claw toe, PIP joint, arthrodesis, resection arthroplasty
- Medical subject headings
- Hammer Toe Syndrome, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrodesisProcedure or surgery
see study group description
Resection arthroplastyProcedure or surgery
see study group description
| Study group | Role | What they receive |
|---|---|---|
| Arthrodesis | Experimental | Arthrodesis of the proximal interphalangeal joint by using a threaded K-wire Receives: Procedure: Arthrodesis |
| Resection arthroplasty | Active comparator | Resection arthroplasty of the proximal interphalangeal joint using a normal K-wire Receives: Procedure: Resection arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Change in pain was evaluated using the Numeric Rating Scale for pain (ranging from 0 (no pain) to 10 (maximum pain))
Measured: Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively
Function
Change in function was evaluated using the American Orthopaedic Foot and Ankle Society score (ranging from 0 (severe impairment) to 100 (no problems with foot))
Measured: Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively
Secondary outcomes (1)
Osseous consolidation
Osseous consolidation of the procedure was evaluated using x-rays
Measured: 6months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study startJan 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Claw ToeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ulf Krister Hofmann, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530839
- Sponsor's protocol ID
- 450/2014BO1
- Status last verified
- May 2018
- First submitted
- 25 Apr 2018
- Last updated
- 21 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03530839
- Acronym / sponsor ID
- 450/2014BO1
- Conditions
- Claw Toe, Lesser Toe Deformity
- Keywords
- lesser toe deformity, claw toe, PIP joint, arthrodesis, resection arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The aim of this study was to compare operative outcomes after lesser toe deformity correction with either proximal interphalangeal (PIP) joint arthrodesis or PIP joint resection arthroplasty.
Methods: A prospective randomized controlled trial was performed on 37 patients (48 toes) who underwent one of these two procedures. The Numeric Rating Scale (NRS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) score, osseous consolidation, and clinical outcome were evaluated preoperatively and at 6 weeks and 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthrodesis | Experimental | Procedure: ArthrodesisArthrodesis of the proximal interphalangeal joint by using a threaded K-wire |
| Resection arthroplasty | Active comparator | Procedure: Resection arthroplastyResection arthroplasty of the proximal interphalangeal joint using a normal K-wire |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with one or more claw toes with rigid PIP joint flexion and extension deformity of the MTP joint scheduled for surgical intervention in the investigator's department
Key exclusion criteria (7 listed)
- known osteoporosis or other bone metabolism disorders
- prior surgery on the toe scheduled for the intervention
- immunodeficiency or immunosuppressive drug intake
- pregnancy
- non-palpable pulses of the posterior tibial artery or the dorsalis pedis artery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthrodesissee study group description | Procedure or surgery | Arthrodesis |
| Resection arthroplastysee study group description | Procedure or surgery | Resection arthroplasty |
Primary outcome
Pain
Time frame: Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively
Change in pain was evaluated using the Numeric Rating Scale for pain (ranging from 0 (no pain) to 10 (maximum pain))
Function
Time frame: Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively
Change in function was evaluated using the American Orthopaedic Foot and Ankle Society score (ranging from 0 (severe impairment) to 100 (no problems with foot))
1 secondary outcome
Osseous consolidation
Time frame: 6months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrodesis and Resection arthroplasty in people with Claw Toe and Lesser Toe Deformity, run by University Hospital Tuebingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.